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ACT Validation

Here is a question from Mary Rozmanc in Sunnybrook:

Hi, George,

I will be evaluating two vendor ACT devices. Is there any information you have or that you can point me to to help me set up a proper evaluation? The reference instrument will be the Medtronic ACT II. I would like to know what type of acceptance criteria I can decide on before I begin the evaluation. Both vendors use ACT cartridges.

Would a cath lab benefit from a high-range ACT test cartridge and when would this be the case?

Thank you, Mary

POCT/Projects Coordinator

Hi, Mary. For a general look at how to set up a comparison study, see our educational modules, Method Validation in Hemostasis 1 and 2. I also submitted your question to Dr. Soumaya El-Rouby, Senior Manager of Clinical Affairs at International Technidyne, Inc. She responds:

“A cath lab would benefit from a high range ACT in case the patients present with heparin on board and the level of heparin exceeds that recommended limit for the low range ACT.  My advice is to compare both types of cartridges (low and high) to the reference method and generate the equivalent ranges.  Each institution determines the acceptance criteria for each system.

Are they going to evaluate an ACT device from ITC?  If so I can have our Tech Support help them determine their reference ranges based on their data.”

I hope this is helpful.

Soumaya El Rouby, Ph.D.
Sr. Manager, Clinical Affairs
International Technidyne Corporation
20 Corporate Place South
Piscataway, NJ 08854
Phone: 1-800-631-5945 ext 221
Fax: 732-635-0144
[email protected]

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